Preparing the Marketing Authorization Application in the EU, With a Focus on the Product Information (Opfikon, Switzerland – April 18-19, 2018) – Research and Markets

the Marketing Authorization Application in the EU, With a Focus on the
Product Information”
conference has been added to Research
and Markets’

In this seminar, we will look into all elements of the MAA dossier, in
particular module 1, and within this module the Product Information. In
addition, the various meetings with the Health Authorities in the
centralized procedure will be discussed.

Regular review and monitoring of product information for medicines is
important, to support awareness of relevant updates/changes which may
affect prescribing, dispensing, administration or monitoring practices.
It is also important that patients and caregivers, as appropriate, are
made aware of the information contained in the Package Leaflet (PL) and
should be encouraged to read it prior to and during their treatment.

The PL reflects the more comprehensive information described in the
SmPC, but is required to be presented in an abbreviated and easy-to-read
format for patients.

The SmPC provides the basis of information for healthcare professionals
to use a medicine safely, effectively and in the most appropriate
manner. It is also a legal document, agreed between the Authorities and
the relevant pharmaceutical company.

The format and content of the SmPC is laid down in EU/national
legislation and regulatory guidance documents. Use of a medicine outside
the conditions/ recommendations described in the SmPC falls under the
responsibility of the healthcare professional.

It is important to note that the SmPC is not intended to provide general
advice on the treatment of particular medical conditions. On the other
hand, specific aspects of the treatment related to use of the medicine,
or its effects may be mentioned. Similarly, general advice on
administration procedures is not included, but any advice specific to
the medicine concerned will be included, if appropriate.

The PL is drawn up in accordance with the SmPC and is subject to
user-testing to ensure its ease of readability by patients/consumers. It
plays an essential part in supporting the safe and effective use of a
medicine by a patient. Consequently, it is important that a PL is
provided each time a product is dispensed. Patients and care-givers
should be encouraged to read the current version of the PL that
accompanies their medicine(s) and to discuss any relevant concerns with
a healthcare professional involved in their care.

Pre-submission meetings with the EMA and Rapporteurs are a vital element
in the preparation of the MAA filing, and knowledge of the how to
conduct these is vital for a successful outcome

Why Should You Attend?

This seminar is specifically designed for personnel that will have to
prepare a Marketing Authorisation Application in the EU. It is important
to do this correctly, as otherwise the application may be rejected at
validation (at the time of submission) or there may be delays later in
the process.

Product Information is a key part of the marketing authorisation of all
medicines authorised in the European Union.

The product information is comprised of the Summary of Product
Characteristics (SmPC) and the PL. These documents are issued when a
medicine is first licensed for use and are reviewed and updated as
necessary throughout the lifetime of a medicine, to reflect the current
state of knowledge of the medicine and the risks associated with its
use. The SmPC is mainly intended for use by healthcare professionals.

SmPCs are also the basis for the preparation of package leaflets, so are
important documents in enabling information on medicines to reach

The labelling and package leaflet are important tools to achieve correct
use of the medicinal product. Marketing Authorisation Holders (MAHs) are
required to ensure that current versions of the labelling and package
leaflet are used when medicines are supplied to pharmacies.

Areas Covered in the Session:

  • SmPC
  • Package Leaflet
  • Labelling
  • Readability testing
  • How to conduct presubmission meetings with the EMA and Rapporteurs

For more information about this conference visit


Research and Markets
Laura Wood, Senior Manager
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Topics: Pharmaceutical